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Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694108
First Posted: September 26, 2012
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hvidovre University Hospital
Kolding Sygehus
Danish National Research Foundation
Research Center for Vitamins and Vaccines (CVIVA)
Information provided by (Responsible Party):
Lone Graff Stensballe, Rigshospitalet, Denmark
Results First Submitted: December 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Prospective
Single-blind
Clinical
Trial
Intervention
Intervention: Biological: BCG-vaccine (SSI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BCG-vaccine No text entered.
Control Children (no Intervention) No text entered.

Participant Flow:   Overall Study
    BCG-vaccine   Control Children (no Intervention)
STARTED   2129   2133 
COMPLETED   2129 [1]   2133 [1] 
NOT COMPLETED   0   0 
[1] 100% follow-up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics by allocation among the 4184 mothers in The Danish Calmette Study

Reporting Groups
  Description
BCG-vaccine SSI strain 1331 standard dose
Control Children No intervention
Total Total of all reporting groups

Baseline Measures
   BCG-vaccine   Control Children   Total 
Overall Participants Analyzed 
[Units: Participants]
 2095   2089   4184 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 32.0  (4.6)   31.9  (4.4)   31.95  (4.5) 
[1] Maternal age
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Female      1003  47.9%      985  47.2%      1988  47.5% 
Male      1092  52.1%      1104  52.8%      2196  52.5% 
[1] Gender of the child. In multiple births: gender of the first born child.
Region of Enrollment [1] 
[Units: Participants]
     
Denmark   2095   2089   4184 
[1] All three study sites are situated in Denmark.
Premature birth 
[Units: Participants]
 61   60   121 


  Outcome Measures
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1.  Primary:   All-cause Hospitalisations   [ Time Frame: 0-15 months of age ]

2.  Secondary:   Antibiotics   [ Time Frame: 0-15 months of age ]

3.  Secondary:   Atopic Dermatitis   [ Time Frame: 13 months of age ]

4.  Secondary:   Specific IgE   [ Time Frame: 13 months of age ]

5.  Secondary:   Standardized Weight at 13 Months   [ Time Frame: 13 months of age ]

6.  Secondary:   Psychomotor Development in Premature Infants   [ Time Frame: 13 months of age ]

7.  Secondary:   DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age   [ Time Frame: 13 months of age ]

8.  Secondary:   Standardized Weight, Length and Head Circumference of Premature Children at 13 Months   [ Time Frame: 13 months of age ]

9.  Secondary:   Episodic Viral Wheeze   [ Time Frame: 13 months ]

10.  Secondary:   Food Allergy   [ Time Frame: 13 months ]

11.  Secondary:   Length at 13 Months of Age   [ Time Frame: 13months ]

12.  Secondary:   Standardized Head Circumference at 13 Months of Age   [ Time Frame: 13 months ]

13.  Secondary:   Thymic Gland Size at 3 Months of Age   [ Time Frame: 3 months of age ]

14.  Secondary:   Leucocyte Count 4 Days After Randomisation/Vaccination   [ Time Frame: 4 days after randomisation/vaccination within 7 days after birth ]

15.  Secondary:   Monocyte Count 4 Days After Randomisation/Vaccination   [ Time Frame: 4 days after randomisation/vaccination within 7 days after birth ]

16.  Secondary:   Interferon Gamma Response   [ Time Frame: 13 months of age ]

17.  Secondary:   Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL   [ Time Frame: 13 months of age ]

18.  Secondary:   Number of Events of Common Cold   [ Time Frame: 13 months of age ]

19.  Secondary:   Number of Events of Pneumonia   [ Time Frame: 13 months of age ]

20.  Secondary:   Number of Events of Febrile Episodes   [ Time Frame: 13 months of age ]

21.  Secondary:   Number of Events With Diarrhoea and Vomiting   [ Time Frame: 13 months of age ]

22.  Secondary:   Number of Events of Acute Otitis Media   [ Time Frame: 13 months of age ]

23.  Secondary:   Number of Events of Febrile Convulsions   [ Time Frame: 13 months of age ]

24.  Other Pre-specified:   Decisional Conflict Scale Score   [ Time Frame: The decisional conflict score was measured before randomisation ]

25.  Other Pre-specified:   Quality of Communication and Information   [ Time Frame: 2 days after the information was given ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The allocation was planned to be stratified by sex, study site, and prematurity, however, due to a programming error the allocation was stratified only by prematurity.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lone Graff Stensballe, Research leader, Pediatrician, PhD
Organization: Rigshospitalet
phone: +0045 35459727
e-mail: lone.graff.stensballe@regionh.dk


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lone Graff Stensballe, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01694108     History of Changes
Other Study ID Numbers: EudraCT2010-021979-85
First Submitted: September 22, 2012
First Posted: September 26, 2012
Results First Submitted: December 3, 2015
Results First Posted: January 8, 2016
Last Update Posted: May 24, 2017